BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN TOUCH EU

    MDR report key: 3023575 · Received March 27, 2013

    Report

    Report Number
    0001831750-2013-02598
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED AS INVESTIGATION FOUND THAT ONLY ELECTRONIC ENGAGEMENT OF THE BRAKES WAS AFFECTED. THE BRAKES COULD STILL BE ENGAGED MANUALLY. THEREFORE, THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT ENGAGING DUE TO MALFUNCTION HEAD AND FOOT END CASTERS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT ENGAGING ELECTRONICALLY DUE TO MALFUNCTIONED HEAD AND FOOT END CASTERS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125746 IN TOUCH EU BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1